Lead Biostatistician (IVD Analytical)

The role

You will oversee the design, analysis, and interpretation of R&D and analytical validation studies for complex biomarkers. This role involves leading biostatistics efforts for CLIA LDT and in vitro diagnostic approvals.

What you will do

• Lead Biostatistics efforts designing and executing analyses for analytical validation studies
• Perform relevant statistical analyses for validation studies of varying complexity
• Produce high quality presentations and author documentation of analysis plans, methods, results, and interpretation
• Convey statistical concepts and results to cross-functional internal and external collaborators and stakeholders
• Identify risks, communicate concerns, and champion solutions to interdisciplinary project teams
• Mentor and provide technical supervision to junior team members

Required qualifications

• Master’s degree in biostatistics, statistics, or equivalent with 5+ years of relevant experience, or PhD in biostatistics, statistics, or equivalent with 3+ years of relevant experience
• Previous diagnostic experience
• Minimum of 4 years practical experience with statistical analysis software such as R
• Experience with SAS or JMP
• Experience designing and executing statistical analyses in a regulated environment
• Expert working knowledge of statistical methodology in diagnostic medicine, including an understanding of CLSI guidelines
• Demonstrated ability and enthusiasm for working on cross-functional teams
• Strong communication skills to explain complex statistical concepts to non-statistical audiences
• Strong track record of producing high quality written documentation for multiple audiences

Nice to have

• Experience negotiating with the FDA
• Prior experience with next-generation sequencing (NGS), genetics, and/or oncology diagnostics
• Familiarity with DNA methylation

Benefits

• Comprehensive medical, dental, vision, life and disability plans
• Free testing for employees and immediate families
• Fertility care benefits
• Pregnancy and baby bonding leave
• 401k benefits
• Commuter benefits
• Employee referral program

About the company

Natera is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. The team consists of statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and other professionals.